A healthcare worker prepares a vaccination for Pfizer coronavirus disease (COVID-19) in Los Angeles, California on January 7, 2021.
Lucy Nicholson | Reuters
Pfizer said it has started a clinical trial testing its Covid-19 Vaccine against healthy children aged 6 months to 11 years, a crucial step in gaining regulatory approval to vaccinate young children and fight the pandemic.
The first study participants have already made their recordings, which were developed in cooperation with the German drug manufacturer BioNTech, Pfizer of New York announced Thursday. In the first phase, 144 children are to be enrolled.
In the first phase of the study, the company will determine the preferred dosage level for three age groups – between 6 months and 2 years, 2 and 5 years, and between 5 and 11 years. The children will first receive a dose of 10 micrograms of the vaccine before gradually moving to higher doses, Pfizer said. Participants also have the option of ingesting 3 micrograms doses. The adult Covid vaccine requires two shots that contain 30 micrograms per dose.
Researchers will then evaluate the safety and effectiveness of the selected dose levels in the next phase of the study, with participants being randomly selected to receive the vaccine or a placebo, the company said. After a six-month follow-up visit, children who received a placebo will have the option to receive the vaccine.
“Pfizer has extensive experience developing clinical trials of vaccines in children and infants and is committed to improving the health and well-being of children through well-designed clinical trials,” the company said in a statement.
Pfizer’s vaccine has already been issued approved for use in the USA for Americans aged 16 and over. Clinical trials testing the vaccine in children whose immune systems may react differently than adults have yet to be completed.
Vaccinating children is critical to ending the pandemic, say public health officials and infectious disease experts. The US is unlikely to achieve herd immunity – or if enough people in a given community have antibodies to a given disease – before children can be vaccinated. According to the government, children make up about 20% of the US population.
Pfizer said so in late January had fully registered The Covid-19 Vaccine Study in Children Ages 12-15. The company announced Thursday that the data in this cohort is “encouraged” and hopes to provide more details about the study “soon”.
Modernawho also has a US-approved vaccine, said on March 16 that it had started testing its shot on children under the age of 12. Moderna started a study in December testing children aged 12 to 17 years.
The Chief Medical Officer of the White House, Dr. Anthony Fauci, said an H.Earlier this month, the committee announced that the US could start vaccinating older children against Covid-19 this fall, while elementary school children may start vaccinating early next year.
Pfizer’s announcement comes two days after the start of an early-stage clinical trial an experimental oral antiviral drug that could be used at the first sign of Covid infection.
Health experts say the world will still need a slew of drugs and vaccines to end the pandemic that has infected more than 30 million Americans and killed at least 545,282 people in just over a year, according to Johns Hopkins University.